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Colitis, UlcerativePhase 3QUASAR JrNCT06260163

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 study testing Guselkumab Subcutaneous and Guselkumab Intravenous in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 61 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Guselkumab Subcutaneous and Guselkumab Intravenous
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
61 sitesin 13 countries
Study dates
19 Jan 2024to 28 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
  • A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
  • Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
  • Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
  • Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids

Who cannot join

  • Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
  • Presence of a stoma
  • Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
  • Have severe colitis or have evidence of Crohn's Disease (CD)

Trial locations and contacts

61 sites in 13 countries.

61 sites in 13 countries

Japan10 sites

  • Tokyo Metropolitan Children's Medical Center

    Fuchū, 183 8561

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • Kobe University Hospital

    Kobe, 650 0017

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861 8520

  • Shinshu University Hospital

    Matsumoto, 390 8621

  • Saga University Hospital

    Saga, 849-8501

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535

  • Tokyo Medical University Hospital

    Shinjuku, 160 0023

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, 230-8765

Other trials in Japan

China8 sites

  • Capital Center For Children's health Capital Medical University

    Beijing, 100020

  • Peking University Third Hospital

    Beijing, 100191

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213004

  • The Childrens Hospital Zhejiang University School Of Medicine

    Hangzhou, 310005

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055

  • Henan Children's Hospital, Zhengzhou Children's Hospital

    Zhengzhou, 450052

Other trials in China

Italy8 sites

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna, 40133

  • AOU Meyer

    Florence, 50139

  • Ospedale S. Spirito, Azienda Sanitaria Pescara

    Pescara, 65124

  • AOU Policlinico Umberto I

    Roma, 00161

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste, 34137

Other trials in Italy

France5 sites

  • Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant

    Bron, 69677

  • Hopital Francois Mitterand

    Dijon, 21000

  • CHRU Lille

    Lille, 59037

  • APHP Hopital Robert Debre

    Paris, 75019

  • CHU Toulouse

    Toulouse, 31059

Other trials in France

Belgium4 sites

  • CHU Charleroi Chimay

    Charleroi, 6042

  • UZ Gent

    Ghent, 9000

  • UZ Brussel

    Jette, 1090

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Norway4 sites

  • Akershus Universitetssykehus

    Lørenskog, 1478

  • Oslo University Hospital

    Oslo, 0450

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9030

  • St. Olavs Hospital

    Trondheim, 7030

Other trials in Norway

Poland4 sites

  • Copernicus Podmiot Leczniczy Sp. z o.o

    Gdansk, 80 803

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302

  • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04 730

Other trials in Poland

Turkey (Türkiye)4 sites

  • Gazi University Medical Faculty

    Ankara, 06560

  • Ankara University Medical Faculty

    Ankara, 6620

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Marmara University Pendik Training Hospital

    Istanbul, 34899

Other trials in Turkey (Türkiye)

United States3 sites

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • NYU Langone Health

    Lake Success, New York, 11042

  • Children's Hospital Oakland

    Oakland, California, 94609

Other trials in United States

Australia3 sites

  • The Kids Research Institute Australia on behalf of the Centre for Child Health Research

    Nedlands, 6009

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    South Brisbane, 4101

  • The Children's Hospital at Westmead

    Westmead, 2145

Other trials in Australia

Portugal3 sites

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649-035

  • Uls Santo Antonio - Cmin

    Porto, 4050-651

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319

Other trials in Portugal

Spain3 sites

  • Hosp. Infantil Univ. Nino Jesus

    Madrid, 28009

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08028

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Denmark2 sites

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • Hvidovre Hospital

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Being tested
Guselkumab Subcutaneous, Guselkumab Intravenous
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guselkumab SubcutaneousDrug

    Also called CNTO1959, TREMFYA

    Guselkumab will be administered subcutaneously.

  • Guselkumab IntravenousDrug

    Also called CNTO1959, TREMFYA

    Guselkumab will be administered intravenously.

Study groups in NCT06260163
Study groupRoleWhat they receive
Open-label Induction Phase: Guselkumab Intravenously (IV)ExperimentalParticipants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.
Receives: Drug: Guselkumab Intravenous
Open-label Induction Phase: Guselkumab Subcutaneously (SC)ExperimentalParticipants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.
Receives: Drug: Guselkumab Subcutaneous
Double-blind Maintenance Phase: Guselkumab Dose Regimen 1ExperimentalAt the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56.
Receives: Drug: Guselkumab Subcutaneous
Double-blind Maintenance Phase: Guselkumab Dose Regimen 2ExperimentalAt the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56.
Receives: Drug: Guselkumab Subcutaneous
Open-label Maintenance Phase: Guselkumab SCExperimentalWeek 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.
Receives: Drug: Guselkumab Subcutaneous

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Clinical Remission at Week 56

    Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.

    Measured: Week 56

Secondary outcomes (21)

  1. Percentage of Participants with Clinical Response at Week 12

    Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.

    Measured: Week 12

  2. Percentage of Participants with Clinical Remission at Week 12

    Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.

    Measured: Week 12

  3. Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12

    Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission.

    Measured: Week 12

  4. Percentage of Participants with Symptomatic Remission at Week 12

    Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.

    Measured: Week 12

  5. United States: Percentage of Participants with Endoscopic Improvement at Week 12

    Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.

    Measured: Week 12

  6. European Union: Percentage of Participants with Endoscopic Healing at Week 12

    Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.

    Measured: Week 12

  7. Percentage of Participants with Clinical Response at Week 56

    Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by >= 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.

    Measured: Week 56

  8. Percentage of Participants With PUCAI Remission at Week 56

    Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission.

    Measured: Week 56

  9. Percentage of Participants with Symptomatic Remission at Week 56

    Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.

    Measured: Week 56

  10. Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12

    Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.

    Measured: Week 56

  11. United States: Percentage of Participants With Endoscopic Improvement at Week 56

    Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.

    Measured: Week 56

  12. European Union: Percentage of Participants With Endoscopic Healing at Week 56

    Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.

    Measured: Week 56

  13. Percentage of Participants Who Achieve Endoscopic Normalization at Week 56

    Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported.

    Measured: Week 56

  14. Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56

    Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1).

    Measured: Week 56

  15. Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56

    Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. Corticosteroid free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56

    Measured: Week 56

  16. Serum Concentration of Guselkumab During Induction Phase

    Serum samples will be analyzed to determine concentrations of guselkumab overtime.

    Measured: From Week 0 to Week 12

  17. Serum Concentration of Guselkumab During Maintenance Phase

    Serum samples will be analyzed to determine concentrations of guselkumab over time.

    Measured: From Week 12 to Week 56

  18. Number of Participants with Incidence of Anti-guselkumab Antibodies

    Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed.

    Measured: Up to Week 68

  19. Percentage of Participants with Adverse Events (AEs)

    Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

    Measured: Up to Week 68

  20. Percentage of Participants with Serious Adverse Events (SAEs)

    Percentage of participants with SAEs will be reported. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly.

    Measured: Up to Week 68

  21. Percentage of Participants with AEs Leading to Discontinuation of Study Intervention

    Percentage of participants with AEs leading to discontinuation of study intervention will be reported.

    Measured: Up to Week 68

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start19 Jan 2024
  3. Primary completion10 Feb 2027 (estimated)
  4. Study completion28 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06260163
Sponsor's protocol ID
CR109251
Other IDs
CNTO1959PUC3001, 2022-001285-35, 2022-502238-22-00
Acronym
QUASAR Jr
Status last verified
Nov 2026
First submitted
7 Feb 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guselkumab Subcutaneous and Guselkumab Intravenous in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 61 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Japan, China, Italy, France, Belgium and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Clinical Remission at Week 56 (time frame: Week 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06260163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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